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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05062993
Other study ID # 98/08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2021
Est. completion date July 1, 2021

Study information

Verified date January 2022
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. The recently introduced pulsed radiofrequency (PRF) technique is widely used to provide relief from chronic pain and studies have shown that PRF stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space The aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - chronic pain in legs or back pain - unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections Exclusion Criteria: - coagulation disorders - psychiatric disorders - rheumatoid disorders - infections

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
caudal epidural pulse radio frequency
A needle is inserted into the caudal epidural space under ultrasound guidance and pulse radiofrequency is administered at 5 Hz using a 5. ms pulse width for 600 seconds at 55 V.

Locations

Country Name City State
Turkey Diskapi Yildirim Beyazit Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Rating Scale(NRS) (0-10) The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity. before procedure
Primary Numeric Rating Scale The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity. 2 weeks after procedure
Primary Numeric Rating Scale The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity. 4 weeks after procedure
Primary Numeric Rating Scale The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity. 8 weeks after procedure
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